Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001002178
Ethics application status
Approved
Date submitted
25/06/2019
Date registered
15/07/2019
Date last updated
28/09/2023
Date data sharing statement initially provided
15/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Peer support after brain injury
Scientific title
Evaluating a sustainable model of peer mentoring in traumatic brain injury: Randomised pragmatic waitlist trial with process evaluation
Secondary ID [1] 296614 0
Nil
Universal Trial Number (UTN)
U1111-1224-0476
Trial acronym
Linked study record
U111-1142-71 This UTN and citation references the feasibility study that preceded this definitive trial.
Kersten, P., Cummins, C., Kayes, N., Babbage, D., Elder, H., Foster, A.,Weatherall, M. Siegert, R. Smith, G. McPherson, K. (2018). Making sense of recovery after traumatic brain injury through a peer mentoring intervention: a qualitative exploration. BMJ Open, 8(10). doi:10.1136/bmjopen-2017-020672

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 310493 0
Condition category
Condition code
Injuries and Accidents 309202 309202 0 0
Other injuries and accidents
Neurological 312040 312040 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The peer mentoring intervention: eight face to face mentoring sessions spread over five months. The session duration would be approximately one hour. Core components: getting to know the mentor; exploring hopes for meaningful participation; exploring barriers and facilitators; mentor supported activities; reflection on supported activities; planning for the future. The mentoring sessions may take place in a rehabilitation facility, at the mentee's home or at another mutually agreed location. How and when these activities are enacted will be tailored to the mentees unique psychosocial context, and mentoring relationship. Our feasibility study findings would suggest the strength of this approach is in the mentor bringing their shared experience to support and enable the mentee to re-engage with life after TBI. Mentors training: mentors will attend a two day interactive workshop held over two separate weeks which will draw on their own recovery experiences and develop their strengths and skills. Workshop topics will include the role of the mentor, the core components of the intervention, the mentoring relationship, managing difficult and /or crisis situations and safety protocols. Mentors will be supported by the local service coordinator, who has experience in neurorehabilitation. They will keep in contact with the mentors through out the intervention, following-up via phone call after each mentor session and through the quarterly group debriefing sessions.
Intervention code [1] 312963 0
Rehabilitation
Comparator / control treatment
Waitlist control. During the wait period the control group receives usual care. For the purposes of this study, usual care is defined as any and all rehabilitation received outside of the study intervention. Waitlist participants allocated to this group will receive the study intervention after the completion of the nine month data collection time point.
Control group
Active

Outcomes
Primary outcome [1] 308173 0
The primary outcome will be mentee participation, measured by the 'Autonomy Outdoors' subscale of the Impact on Participation and Autonomy (IPA) as measured at 26 weeks immediately post intervention.
Timepoint [1] 308173 0
22 weeks (immediately post-intervention)
Secondary outcome [1] 354149 0
Mentee mood and well being captured using a collection of standardised self report measures including: a) The Short Warwick-Edinburgh Mental Well-Being Scale; b) The Satisfaction with Life Scale; c) Herth Hope index; and d) General self efficacy scale. This is a composite secondary outcome.
Timepoint [1] 354149 0
Assessments will be carried out at baseline, 11, 22 (immediately post-intervention) and 35 (five-month post-intervention completion) weeks
Secondary outcome [2] 354154 0
Health-related quality of life captured using the EQ-5D
Timepoint [2] 354154 0
Assessments will be carried out at baseline, 11, 22 (immediately post-intervention) and 35 (five-month post-intervention completion) weeks
Secondary outcome [3] 354159 0
Mentee productivity status, including satisfaction with current productivity status captured by self-report questions specifically designed for this study
Timepoint [3] 354159 0
Assessments will be carried out at baseline, 11, 22 (immediately post-intervention) and 35 (five-month post-intervention completion) weeks
Secondary outcome [4] 354162 0
Mentee health service resource use will be measured by self report of health social service utilisatiion, medication homecare and out of pocket expenses. Questions designed specifically for this study.
Timepoint [4] 354162 0
Assessments will be carried out at baseline, 11, 22 (immediately post-intervention) and 35 (five-month post-intervention completion) weeks
Secondary outcome [5] 354174 0
Mentor mood and well being as a composite secondary outcome will be captured using standardised self report measures including: a) The Short Warwick-Edinburgh Mental Well-Being Scale; b) Hospital Anxiety and Depression Scale;
Timepoint [5] 354174 0
At the time of mentor recruitment and on completion of intervention delivery phase of the project.
Secondary outcome [6] 371951 0
Process Evaluation data to determine key process variables relating to context and implementation relevant for future service delivery for optimal effectiveness and uptake will be collected using qualitative semi structured questionnaires and in-depth interviews with mentees and mentors.This data will be collected through questionnaires specifically designed for this study.
Timepoint [6] 371951 0
At 22 weeks (immediately post intervention) (mentees) and on completion of intervention delivery phase (mentors).
Secondary outcome [7] 372472 0
Mentor productivity status will be captured using a specifically designed self-report questionnaire
Timepoint [7] 372472 0
Baseline and end of intervention delivery period

Eligibility
Key inclusion criteria
Mentees: People will be eligible to take part if they have moderate or severe TBI (Initial Glasgow Coma Scale score less than 13 and/or post-traumatic amnesia duration of more than one hour)
or people with mild TBI experiencing persistent difficulties (>6 months post injury) impacting on their participation in ways that are important to them and are:
• up to 3 years post-injury;
• at least 16 years old;
• able to communicate with the mentor and researcher (with or without assistance)
• capable of giving informed consent (or assent if under 18 years of age)
• living within one of the three study regions (Auckland, Gisborne, and Northland)

Mentors: People will be eligible to apply for the role of mentor if they are:
• 18 years of age or older
• up to six years post TBI
• at least one-year post discharge from inpatient rehabilitation
• satisfied with their current level of participation, health and well-being
• able to communicate and engage in intervention delivery
• living within one of the three study regions (Auckland, Gisborne, and Northland)
• available during the peer mentoring intervention period
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mentees will be excluded if 1) their medical situation is considered unstable and could severely limit participation in mentoring activities or 2) they are enrolled in other intervention trials
Mentors will be excluded if they 1) experience persistent drug or alcohol difficulties, 2) have a recent history of violence, 3) criminal record checks indicate significant potential ongoing risk, and/or 4) they are experiencing severe mental illness that would impact their ability to fulfil mentor roles and responsibilities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The mentors, study manager, principal investigator and local service coordinators will necessarily know the allocation after randomisation. The data manager and study statistician will be aware of group allocation after randomisation but will not be aware of which group equates to intervention versus control. Randomisation will be carried out centrally by the the data manager who will communicate this to the local service coordinator online. The research manager will hold randomisation allocation in sealed opaque envelopes. The researcher collecting outcomes data will not be told group allocation and will remind participants not to disclose.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation by a statistician using a fixed block size of four, stratifying by intervention site (Auckland, Northland, Gisborne) and ethnicity (Maori, Non-Maori).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Waitlist control will receive the intervention after the 9 month data collection
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis of the continuous variables will be ANCOVA with baseline measurement as a co-variate and randomised treatment as the main explanatory predictor variable after 22 weeks. Secondary analyses will be to model mentors as a random effect in a mixed linear model to determine if there is a strong element of correlated data within mentors and if so to estimate the relevant ICC. Content analysis will be applied to Qualitative data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
6/07/2020
Actual
6/07/2020
Date of last participant enrolment
Anticipated
31/03/2022
Actual
31/03/2022
Date of last data collection
Anticipated
2/10/2023
Actual
Sample size
Target
46
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 21052 0
New Zealand
State/province [1] 21052 0
Auckland, Northland, Gisborne

Funding & Sponsors
Funding source category [1] 301191 0
Government body
Name [1] 301191 0
Health Research Council of New Zealand
Country [1] 301191 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
Centre for Person Centred Research
School of Clinical Sciences
North Campus
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 300871 0
None
Name [1] 300871 0
Address [1] 300871 0
Country [1] 300871 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301931 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 301931 0
Ethics committee country [1] 301931 0
New Zealand
Date submitted for ethics approval [1] 301931 0
23/05/2019
Approval date [1] 301931 0
24/06/2019
Ethics approval number [1] 301931 0
19/NTB/82

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88602 0
Prof Nicola Kayes
Address 88602 0
Centre for Person Centred Research
School of Clinical Sciences
AUT University
North Campus
Private Bag 92006
Auckland 1142
Country 88602 0
New Zealand
Phone 88602 0
+64 9 921 9999 x7309
Fax 88602 0
Email 88602 0
[email protected]
Contact person for public queries
Name 88603 0
Nicola Kayes
Address 88603 0
Centre for Person Centred Research
School of Clinical Sciences
AUT University
North Campus
Private Bag 92006
Auckland 1142
Country 88603 0
New Zealand
Phone 88603 0
+64 9 921 9999 x7309
Fax 88603 0
Email 88603 0
[email protected]
Contact person for scientific queries
Name 88604 0
Nicola Kayes
Address 88604 0
Centre for Person Centred Research
School of Clinical Sciences
AUT University
North Campus
Private Bag 92006
Auckland 1142
Country 88604 0
New Zealand
Phone 88604 0
+64 9 921 9999 x7309
Fax 88604 0
Email 88604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
New Zealand and specifically the regions have a small population and protecting the anonymity of participants can be difficult. We would not like to risk identification and cause any undue harm to participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18609Study protocolKayes N, Cummins C, Weatherall M, et al Randomised pragmatic waitlist trial with process evaluation investigating the effectiveness of peer support after brain injury: protocol BMJ Open 2023;13:e069167. doi: 10.1136/bmjopen-2022-069167  
20520Statistical analysis plan    376386-(Uploaded-18-09-2023-10-12-58)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomised pragmatic waitlist trial with process evaluation investigating the effectiveness of peer support after brain injury: Protocol.2023https://dx.doi.org/10.1136/bmjopen-2022-069167
N.B. These documents automatically identified may not have been verified by the study sponsor.